Greg Shipp, Md work email
- Valid
- Valid
- Valid
- Valid
- Valid
- Valid
Greg Shipp, Md personal email
- Valid
Greg Shipp, Md phone numbers
Accomplished executive with 30 years experience in medical, regulatory, and clinical affairs at major medical device companies and smaller start-up organizations. Trained as a diagnostic radiologist and biomedical engineer. Has skillfully led discovery, development, and delivery of products across diverse therapeutic and diagnostic areas, including guided pharmaceutical therapies, companion diagnostics, and implantable medical devices. Experienced in oncology, cardiology, pharmacogenomic, and infectious disease applications. Guided a multinational team in successfully writing CERs, CEPs, PMCFs, and SSCPs for ophthalmic and aesthetic medical device implementation. Has capably coordinated all operational aspects of clinical studies and trials according to standard operating procedures, study protocols, and domestic and international regulatory guidelines.Energetic professional who maintains strong partnerships with internal customers, vendors, principal investigators, clinical research organizations, and key opinion leaders. Frequently speaks at national and regional clinical, medical, and regulatory meetings and represents the organization at scientific seminars, symposia, forums, and medical conferences. Possesses exceptional leadership and mentoring skills to motivate teams, facilitate open collaboration among units, and spur employees to high levels of performance. Valued, respected professional recognized for innovation, integrity, and strong work ethic.Specialties: Medical Devices including implantables • Multiplexed Genetic Assays • Immunoassays • Companion Diagnostics • Guided Pharmaceutical Therapies • Investigator-Initiated Studies • Clinical Trials • Data Analysis & Reporting • FDA & NIH Contact • Class II & III Regulatory Submissions & Compliance • KOL Management • Outcomes Research • Business Planning • Team Development, Mentoring, & Supervision • Strategic Planning • Resource Management • Matrix Environments • Project/Program Management
Directpath Llc
-
PresidentDirectpath Llc May 2022 - PresentExpert medical, clinical, and regulatory affairs consulting. 30 yrs experience at start-up and major medical device companies. Biomedical engineering and clinical medicine background.
-
Director, Global Medical Devices/Clinical Evaluation GroupBausch Health Companies Inc. Aug 2017 - Apr 2022Laval, Quebec, CaProvided leadership to the Clinical Evaluation Group, including authoritative opinions and answers to medical-based questions concerning the clinical evaluation of medical devices for submission of clinical/regulatory documents to global regulatory authorities. Ensured collaboration between cross-functional groups to ensure successful clinical evaluation outcomes. Provided clinical/medical analysis for and response to current and new guidelines/regulations (e.g. the EU Medical Device Regulation (MDR)). -
Director, Regulatory And Clinical StrategyCreavo Medical Technologies Ltd Jul 2015 - Dec 2016CREAVO Medical Technologies is a privately held medical device company committed to the application and utilization of advanced Quantum principles to the passive and rapid detection of a range of potentially life threatening medical conditions, including cardiac ischemic diagnosis in acute care settings.Developed the clinical, regulatory, and quality strategies/plans to bring the diagnostic imaging device to market globally. Managed the operational tasks to efficiently and successfully execute the plans. -
Senior ConsultantHalloran Consulting Group, Inc. Aug 2013 - Jun 2015Boston, Massachusetts, UsProvided strategic medical, clinical, and regulatory advice on clinical trial design development, executed clinical and regulatory strategy, led scientific literature reviews, performed organizational assessments and gap analyses, and made recommendations to clients. -
Director, Clinical ResearchRegenesis Biomedical, Inc. Jan 2012 - Jun 2013Led the clinical team to design and execute the company's clinical trial strategy to produce a clinical evidence-base for regulatory, reimbursement and commercial positions. Led a 139-subject randomized, double-blind, sham-control clinical trial to demonstrate the safety and effectiveness of pulsed radiofrequency energy (PRFE) for relief of acute post-operative pain.
-
Vp Of Clinical And Regulatory Affairs / Chief Medical OfficerNanosphere, Inc. Jun 2005 - Jan 2012Northbrook, Il, UsDeveloped strong working relationships and beneficial partnerships with members of molecular diagnostics and chemistry laboratory communities; physicians; CMS and other third-party payers; and FDA. Led clinical studies and obtained FDA clearances for the 2 versions of the Verigene instrument and the first 6 genetic and infectious disease test cartridges. Successfully constructed the study design for, protocol for, and execution of a multinational, 16-site, 1500+ patient clinical trial to evaluate improvement in outcomes with the use of a high-sensitivity cardiac troponin assay in the diagnosis of acute coronary syndromes (ACS). -
Vp, Medical Affairs; Chief Medical ExecutiveAbbott Point Of Care 2002 - 2005Abbott Park, Illinois, UsProvided strategic leadership and oversight for scientific/medical activities for the i-STAT product; prepared global clinical strategies and plans, reviewing protocols and evaluating medical/clinical data to provide assessments and recommendations of reports submitted to regulatory authorities. Established, maintained, and fostered strong working relationships with medical and clinical laboratory communities, as well as customer base. Managed partnerships with laboratory medical directors and clinical physicians, including emergency physicians, cardiologists, cardiothoracic surgeons, intensivists, and laboratorians, worldwide. Supervised cross-functional team of six direct reports, including clinical affairs personnel, senior medical writer, and clinical chemists. • Liaised between customer and design/process engineers, which improved product quality and reduced clinical risk. • Executed post-market clinical studies that expanded evidence base for improvement in patient outcomes with point-of-care testing, thereby assuring reduction in overall health care costs. • Provided direction and expertise to clinical affairs team to enhance efficiency, content, and utility in clinical study work associated with regulatory clearances in U.S., Canada, and Europe. • Trained sales, marketing, implementation, and technical service personnel on medical physiology, current scientific literature, and clinical insights into discrimination between competitive technologies. -
Director Of Clinical AffairsBoston Scientific 1999 - 2002Marlborough, Ma, UsSupervised team of 3 clinical research associates, managed development of clinical protocol, clinical risk analysis, case report forms, informed consent forms, and investigational plans for domestic and international clinical evaluation of Type III implantable stent-graft for endovascular exclusion of infra-renal abdominal aortic aneurysms. Implemented and executed study with 366 patients across 17 clinical sites; managed contracts, study budgets, and IRB approvals. Monitored site activities to ensure compliance with GCPs and IDE and ICH guidelines. Secured FDA and Ethical Committee approvals and facilitated post-approval and post-market studies. • Conducted extensive data reviews regarding product and ultimately made difficult decision to terminate 3-year clinical study of abdominal aortic aneurysm (AAA) stent-graft after determining that adverse safety results were substantial. • Played key role in defining clinical/regulatory strategies for international/domestic clinical evaluations. -
Medical DirectorBio-Reg Associates 1995 - 1999Led teams of up to 15 associates in numerous clinical studies of Class III medical devices. Maintained regular contact with both clients and FDA representatives. Designed, refined, and implemented protocols in alignment with GCPs; performed extensive data analysis and authored PMA clinical section. Designed retrospective clinical studies of urine and serum samples for evaluation of 4 separate Class II in vitro diagnostic (IVD) bone marker devices for indications of bone resorption and bone formation monitoring. Created prospective clinical study to evaluate diurnal variation in urine bone markers as measured by IVD devices. Wrote clinical and statistical sections of all premarket clearances and received 510(k) clearances for all IVD devices within 9 months of submission. Additional clinical studies include:• Ophthalmology: refractive laser surgery devices; approximately 1,200 subjects in 6 separate studies; 4 successful PMA submissions produced.• Plastic Surgery: ultrasound-assisted lipoplasty device; approximately 500 subjects• Urology: extra-corporeal shock wave lithotripsy device; approximately 200 subjects• Bone Physiology: ultrasound bone densitometer for osteoporosis and fracture prediction; approximately 300 subjects
Greg Shipp, Md Skills
Greg Shipp, Md Education Details
-
University Of North Carolina At Chapel Hill School Of MedicineMedicine -
Northwestern UniversityBiomedical Engineering
Frequently Asked Questions about Greg Shipp, Md
What company does Greg Shipp, Md work for?
Greg Shipp, Md works for Directpath Llc
What is Greg Shipp, Md's role at the current company?
Greg Shipp, Md's current role is Independent Consultant.
What is Greg Shipp, Md's email address?
Greg Shipp, Md's email address is gw****@****aol.com
What is Greg Shipp, Md's direct phone number?
Greg Shipp, Md's direct phone number is +148064*****
What schools did Greg Shipp, Md attend?
Greg Shipp, Md attended University Of North Carolina At Chapel Hill School Of Medicine, Northwestern University.
What skills is Greg Shipp, Md known for?
Greg Shipp, Md has skills like Medical Devices, Fda, Clinical Trials, Regulatory Affairs, Oncology, Clinical Research, Infectious Diseases, Biotechnology, Cardiology, Pharmaceutical Industry, Regulatory Submissions, Clinical Development.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial